FDA product code LEI: Implant, Anti-Gastroesophageal Reflux
LEI is the FDA product code for implant, anti-gastroesophageal reflux. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under LEI reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 5 recalls for LEI devices.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Anti-Gastroesophageal Reflux |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LEI devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-04-20.
| Year | Recalls |
|---|---|
| 2018 | 5 |
Frequently asked questions
What is FDA product code LEI?
LEI is the FDA product code for implant, anti-gastroesophageal reflux. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is LEI?
Class III. Typical premarket route: PMA.
Have LEI devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2018-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LEI
- Run a recall and safety report across every LEI manufacturer
- Watch product code LEI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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